Label: JUST RIGHT- 0.243% sodium fluoride toothpaste gel, dentifrice
- NDC Code(s): 57511-0124-1
- Packager: Elevate Oral Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2024
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OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride 0.243% (0.15% w/v fluoride ion) Anticavity
INDICATIONS & USAGE SECTION
helps protect against cavities
WARNINGS SECTION
Keep out of reach of children under 6 years of age: if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children under 6 years of age:
INSTRUCTIONS FOR USE SECTION
Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.35 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.
INACTIVE INGREDIENT SECTION
Inactive ingredients; sorbitol, water, glycerin, hydrated silica, PEG-8, FD&C Red 40, sodium lauryl sulfate, potassium phosphate monobasic, xanthan gum, flavor, sodium saccharin, sodium benzoate, mica
OTC - QUESTIONS SECTION Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com
OTC - PURPOSE SECTION Helps protect against Cavities
DOSAGE & ADMINISTRATION SECTION Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.35 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JUST RIGHT
0.243% sodium fluoride toothpaste gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57511-0124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.243 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN (UNII: FST467XS7D) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color red Score Shape ROUND Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57511-0124-1 93.3 g in 1 TUBE; Type 0: Not a Combination Product 05/07/2013 01/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 05/07/2013 02/01/2020 Labeler - Elevate Oral Care (002863526) Registrant - Elevate Oral Care (002863526) Establishment Name Address ID/FEI Business Operations Elevate Oral Care 002863526 manufacture(57511-0124)
